MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SN60WF

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Visual Impairment (2138); Disability (2371)

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.Additional information has been requested.(b)(4).

Event Description

A consumer reported that she has found an article that shows other patients with problems.In a literature article titled the subtle presence of iol glistenings highlights the importance of checking for easily found problems first, the authors reported a (b)(6) patient who experienced hazy vision, especially in dim light, along with increased glare at night two years following bilateral intraocular lens (iol) implant procedures.The patient said ¿i can¿t see anything at dusk or after sunset.¿ she had a residual refractive error (+1.00 d ou), yet her bcva was 20/20 ou.The patient reported her vision was not clear even with glasses.Upon examination, microvacuoles were observed within the substance of the lenses.A 4+ glistenings covering 80% of the surface of the lens in the right eye.In the left eye, there were 3+ glistenings, corresponding to the severity of the patient¿s reported disability.There are two medical device reports associated with this patient.This report is for the left eye.

Manufacturer Narrative

Correction - literature article has been attached.The manufacturer internal reference number is: (b)(4).Literature articles 23 apr 2018.

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7532263
• MDR Text Key: 108852501
• Report Number: 1119421-2018-00640
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,literature
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.XXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 05/22/2018
• Supplement Dates FDA Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR